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BNP Evaluation Before Surgery Study

2019-10-09 09:21:39 | BioPortfolio

Summary

A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.

Description

Study rationale:

Every year about 230 million adults undergo major non-cardiac surgery around the world. In patients 45 years and older the 30-day mortality rate is 2%. One in 20 patients will have myocardial injury that contributes to subsequent 30-day mortality and morbidity up to one year after surgery.

Identification of these high-risk patients requires risk stratification. Current clinical risk stratification tools, like the Revised Cardiac Risk Index (RCRI), only have a moderate ability to identify these patients. International guidelines, like Canadian Cardiovascular Society on perioperative cardiovascular risk assessment, advocate that all patients 45yrs and older or patients >18yrs who have significant cardiovascular disease and who are coming for intermediate to high-risk surgery, should get natriuretic peptide (NP) testing. This is because raised preoperative B-type natriuretic peptides have a strong association with postoperative cardiac complications according to observational studies and meta-analyses.

However, in these patients with significant cardiovascular disease coming for intermediate to high-risk surgery it is unknown how many patients will actually have raised natriuretic peptides. That is, which group of patients have an even higher risk in this already high-risk group. Natriuretic peptide (NP) testing is also expensive. Narrowing down the number of patients that need to be tested will reduce costs and focus efforts on those patients who really need it.

Primary objectives Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.

Secondary objective The secondary objective is to develop a risk prediction model for those patients who will need preoperative NP testing.

Study design This is a multi-centre, prospective observational study of elective adult, non-cardiac surgical patients, 45 years or older with significant cardiovascular disease conducted over a period of four weeks.

Patients will be recruited during the preoperative assessment, usually the day before surgery. Patients will have the usual standard care risk assessment. Informed consent to have NP testing can be obtained from patients who fulfil the inclusion criteria. Patients who refused consent will continue to surgery and have access to usual care provided at the hospital institution where they have been admitted.

In patients that fulfill the surgical and clinical inclusion criteria for NP testing can be done during the preoperative visit. NP tests will be sent to the laboratory and clinicians will be blinded to the results.

Based on an individual patient data meta-analysis of mixed non-cardiac surgical patients BNP≥100 or NT-proBNP≥300 will be considered above the diagnostic threshold.

Inclusion criteria The VISION study identified preoperative patient characteristics that are associated with mortality within 30 days of major non-cardiac surgery.

The patient population to be studied are elective patients for non-cardiac surgery.

1. Age ≥ 45 years of age.

2. Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.

3. With at least one of the following criteria:

1. History of ischaemic heart disease/peripheral vascular disease (coronary equivalent),

2. History of stroke or transient ischaemic attack,

3. History of congestive cardiac failure,

4. Diabetes currently on an oral hypoglycaemic agent or insulin or

5. Serum creatinine >175 µmol/L (>2.0mg/dl).

Exclusion criteria

1. Patient refusal to participate.

2. Patients presenting for cardiac and obstetric or emergency surgery.

Study Design

Conditions

Risk Stratification in Surgical Patients With Cardiovascular Risk Factors

Location

Groote Schuur Hospital
Cape Town
Western Cape
South Africa
7935

Status

Not yet recruiting

Source

University of Cape Town

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-09T09:21:39-0400

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